Identity
- Trade Name
- JianQi EUDAMED
- Device Name
- Medical Mask EUDAMED
- Model / Reference
- JXKZ001-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974194581000 EUDAMED
- Basic UDI-DI
- 697419458011MU EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
JianQi by Ningbo JianXiang Packaging Material Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697419458011MU | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010447
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 9beb9083-7609-4a8b-8414-e8aadff7e06c 61 fields · synced Jun 18, 2026